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A Day in the Life of a Regulatory Affairs Associate…
On a daily basis, with support from your line manager, you will be working cross-functionally with R&D colleagues to:

Ensure dossier technical content is optimal and aligned with EU Regulatory data requirements for new EU Marketing Authorisation Applications and post approval variations, where required
Perform the necessary regulatory activities for your assigned projects from pre-submission until post-approval handover to regulatory maintenance teams. This includes review and optimisation of dossier content (particularly Module 3), compilation and submission of files, resolution of Health Authority questions in cooperation with other functions, and submission of variations where required
Ensure that files and responses are submitted and approved on time
Communicate regulatory information for assigned projects before, during and after approval and provide regulatory support to project teams, stakeholders and customers, as required 
Track and monitor queries/deficiency letters/commitments from/to European Health Authorities to ensure these are implemented and conformed to in a timely manner
Ensure that all activities fully comply with departmental and company SOPs and that all internal tracking tools and databases are maintained, accurate and complete

Through training and on the job experience you will develop and grow your understanding of the European regulatory environment and supporting data requirements.
Who we are looking for
Do you have…?

Pharmacy/Chemistry or Life Sciences degree
Regulatory Affairs experience ideally with medicines, medical devices, OTCs…. We are also happy to consider candidates coming with R&D and/or Formulation background.
Knowledge of:

Pharmaceutical & scientific processes
Regulatory requirements, process, procedures, & pathways

Internal/external communications skills (written & oral) and collaboration skills (local/regional)
Good attention to detail and time management skills

 
Are you…?

Able to work within a team and with independence on all routine activities
Self-motivating
Open to change
Analytical